Cleared Traditional

K143757 - ANUTRA Feedback Aspiration Syringe

K143757 is an FDA 510(k) clearance for ANUTRA Feedback Aspiration Syringe, manufactured by Anutra Medical, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K143757 · Anutra Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
8d
Days
Class 2
Risk

K143757 is an FDA 510(k) clearance for the ANUTRA Feedback Aspiration Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Anutra Medical, Inc. (Morrisville, US). The FDA issued a Cleared decision on January 8, 2015 after a review of 8 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K143757

510(k) Number K143757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2014
Decision Date January 08, 2015
Days to Decision 8 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 129d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 587
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K143757.
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FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.